Cold Storage System for Storing Pharmaceutical Product Containers

ABSTRACT

Intelligent refrigerator system for storing pharmaceutical product containers, such as vials, ampules, syringes, bottles, medication tubes, blister packs and cartons, at the point of dispensing. Embodiments of the invention use product identification technology, such as radio-frequency identification (RFID) tags and readers, to uniquely identify containers as they are added to or removed from the cold storage compartment of the refrigerator, and automatically retrieve from a local or remote database a variety of details associated with the containers and their contents, such as manufacturing data, expiration dates, time out of refrigeration, inventory levels, safety information, usage statistics, known contraindications and warnings, etc. If the details indicate that there is a problem with a particular pharmaceutical (e.g., that it is counterfeit, expired, suspect, spoiled, recalled or almost depleted), then a message or warning is automatically delivered to a human operator via an attached output device, such as a display screen, speaker or printer. Embodiments of the invention may also be configured to monitor and report temperature faults, power failures and other anomalies associated with the refrigerator or cold storage compartment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/250,015, filed Apr. 10, 2014, which is a continuation of U.S.application Ser. No. 12/832,714, filed Jul. 8, 2010, now U.S. Pat. No.8,756,122, which is a continuation of U.S. application Ser. No.11/913,096, filed Oct. 30, 2007, now U.S. Pat. No. 7,775,056, which is aU.S. national stage entry of PCT/US2007/060524, filed Jan. 12, 2007,which claims priority to U.S. Provisional Application No. 60/759,738,filed Jan. 18, 2006, all of which are hereby incorporated by referencein their entirety.

FIELD OF THE INVENTION

The present invention relates generally to cold storage systems forpharmaceutical product containers.

BACKGROUND OF THE INVENTION

Refrigerated pharmaceutical products, such as vaccines, are verysensitive to rises in temperature and the passage of time. Professionalswho dispense these products know that their quality, effectiveness andsafety depends, to a very large extent, on the temperature conditions atthe location where they are stored, the length of time before beingused, as well as the total amount of time the products have been outsideof refrigeration since they were manufactured.

Generally speaking, refrigerated pharmaceutical products are alsovaluable and expensive, which attracts a large number of companies andindividuals interested in marketing and distributing generic andcounterfeit versions of high-demand pharmaceutical products forfinancial gain. Therefore, for health, safety and liability reasons,professionals who dispense branded pharmaceutical products must also bevery concerned with maintaining the appropriate level of inventory onhand, acquiring additional products only from authorized sources,verifying the authenticity of the products received from authorizedsources, and keeping track of the location or dispensing of everyauthorized product container.

Pharmaceutical product containers are usually marked with a product'sname, manufacturer and expiration date. But these details are usuallychecked manually and only by visual inspection, which can lead tomistakes. These mistakes can have severe, long-lasting or permanentconsequences. Moreover, the product's name, manufacturer and expirationdate are only three of potentially dozens of very significant detailsassociated with a particular pharmaceutical product container, whichdetails the dispensing professional may need to take into account at thepoint of dispensing the product.

For instance, in addition to knowing the product's name and expirationdate, a dispensing professional often needs or wants to know how longthe particular product can stay outside of refrigeration withoutspoiling or losing its effectiveness. She may also want or need to knowhow long the product actually has been outside of refrigeration, eitherbecause the product was temporarily removed from the refrigerator orbecause the refrigerator in which it was kept temporarily loss power.She may also wish to know whether the pharmaceutical product has beenrecalled, whether it is authentic or counterfeit, whether therefrigerator where the product is kept is working properly, as well as avariety of other significant details too numerous to track manually.

Unfortunately, the conventional refrigerators for pharmaceutical productcontainers provide no way for physicians and other health careprofessionals to accurately and precisely ascertain these additionalproduct details. Therefore, there is considerable need in the healthcareindustry for a refrigerator for pharmaceutical product containers whichprovides a variety of pertinent details about the individual productcontainers that are inside the refrigerator, or that are being added orremoved from the refrigerator, as well as a variety of significantdetails concerning the status and operation of the refrigerator itself

SUMMARY OF INVENTION

The present invention addresses the above-described needs, as well asother shortcomings associated with the conventional pharmaceuticalproduct refrigerators, by providing an intelligent refrigerator forstoring pharmaceutical product containers, such as vials, ampules,syringes, bottles, jars, medication tubes, blister packs and cartons,which, among other things, uniquely identifies pharmaceutical productcontainers as they are added to or removed from the cold storagecompartment, and reports to a human operator a variety of informativedetails and/or warnings associated with the uniquely-identifiedpharmaceutical product containers. Embodiments of the invention may alsobe configured to monitor and report to the human operator statusanomalies associated with the cold storage compartment, and to performcertain functions necessitated by of the occurrence of such anomalies.

More specifically, embodiments of the invention automatically retrievefrom a local or remote database a variety of details associated with thepharmaceutical product containers and their contents, such asmanufacturing data, expiration dates, time out of refrigeration,inventory levels, safety information, usage statistics, and knowncontraindications and warnings. If the set of details indicates thatthere is a problem with a particular pharmaceutical (e.g., that it iscounterfeit, expired, suspect, spoiled, recalled or almost depleted),then a message or warning may be automatically delivered to a humanoperator via an attached output device, such as a display screen,speaker or printer. Embodiments of the invention may also be configuredto monitor and report temperature faults, power failures and otheranomalies associated with the refrigerator or cold storage compartment.Embodiments of the invention may include one or more input devices, suchas a touchpad, keyboard or mouse, which the human operator may use toprovide operational instructions or print reports. Some embodiments alsomay be configured to automatically reorder pharmaceuticals when theproduct details indicate that a current inventory of any particularpharmaceutical has fallen below a specified level.

In general, embodiments of the invention comprise a cold storagecompartment, a product identifier, a local database, an interface to apharmaceutical product database, and one or more processors configuredto monitor and manage certain events related to the pharmaceuticalproduct containers. An event occurs, for example, when a pharmaceuticalproduct container is added to or removed from the refrigerator's coldstorage compartment, or when sensors indicate that there has been apower failure or an adverse temperature change.

The local database and the pharmaceutical product database are bothconfigured to store a set of pertinent details associated with thepharmaceutical product container, such as the name of the vaccine,biologic, antitoxin or other compound it contains, the name of themanufacturer, the lot number, the date of manufacture, an expirationdate, storage and refrigeration requirements, warnings, dosage, useinstructions, etc. The pharmaceutical product database, which istypically pre-populated and provided by the manufacturer of thepharmaceutical, may reside on a remote computer system connected to aninterconnected data communications network, such as the Internet or acorporate intranet, or on a permanent or removable memory storage arealocated within or attached to the refrigerator. If the pharmaceuticalproduct database resides on a remote computer system attached to a datacommunications network, then the interface comprises a network interfaceto the data communications network. If the pharmaceutical productdatabase resides in a local memory storage area, such as a CDROM orflash memory device, then the interface will typically comprise a busand bus adaptor configured to provide a communications path between thememory storage area and one or more microprocessors executing theinstructions provided by the one or more event monitoring and eventmanaging processors.

The product identifier can be implemented using a variety of differentproduct identification technologies, including but not limited toradio-frequency identification (RFID) tags and readers, barcode labelsand readers and magnetic stripes and magnetic stripe readers. In someembodiments of the invention, for instance, an RFID reader and antennaare used to detect and decode a unique identifier (called a “tag”)transmitted from a transponder embedded in the pharmaceutical productcontainer. When the pharmaceutical product container with thetransponder enters or leaves the antenna's read zone (i.e., itsreception range), the RFID reader decodes the transponder signalproduced by the pharmaceutical product container to determine the uniqueidentifier associated with the container. Then the one or more eventprocessors use the unique identifier to perform a variety of actions,such as determining whether the container has exceeded a time out ofrefrigeration limit, updating the location information for the containerin the local database, sending an alert to the human operator of therefrigerator, and the like. Depending on the unique identifier receivedand the set of details associated with the unique identifier, the eventprocessor may, in some cases, do nothing in response to the event (forexample, if a duplicate read of the same container has occurred).

The event monitoring and event managing processor(s) may be embodied,for example, in one or more software application programs, routines ormodules configured to be executed by a general purpose microprocessor,in one or more hardware devices, such as a programmable logic controller(PLC), in one or more firmware devices, or in some combination ofsoftware application programs, hardware and/or firmware devices.Typically, although not necessarily, the event monitoring processor(hereinafter referred to as the event monitor) is configured to monitorand detect new events associated with pharmaceutical product containersplaced in or near the refrigerator, as well as to monitor and detect newevents associated with the refrigerator itself. In some embodiments, theevent monitor will generate event codes indicating what type of eventhas occurred. The event managing processor (hereinafter referred to asthe event manager) typically carries out a series of instructions thatare appropriate for the particular event that has just occurred.Notably, alternative embodiments of the invention may use fewer or morePLCs, computer software programs, modules or routines to perform thesame functions as the event monitor and event manager. In someembodiments, for example, the functions of the event monitor and theevent manager may be performed by the same hardware or softwareprocessor.

The product identifier and the event monitor will together determine theunique identifier for the container and what event has just occurred,such as whether the product container has been added or removed from therefrigerator. If event codes are used, then the event monitor will thengenerate an appropriate event code. The event manager receives the eventcode and the unique identifier from the event monitor and, depending onwhich event code was received, performs the appropriate action and/ortransmits the appropriate message or warning to the human operator viaan output device attached to the refrigerator.

For example, when a human operator places a pharmaceutical productcontainer onto a shelf in the cold storage compartment, the containerwill necessarily pass into the read zone of an antenna located on, in ornear the shelf. The antenna picks up a self-identifying signaltransmitted from the transponder embedded in the container and sends thesignal to the RFID reader. The RFID reader decodes the self-identifyingsignal to determine the unique identifier (tag) for the container andpasses this information to the event monitor. The event monitorgenerates an “added item” event code signifying the fact that a productcontainer has been added to the refrigerator (as opposed to beingremoved) and passes this information to the event manager, which thenexecutes a series of checks and/or other actions associated with addingitems to the refrigerator.

For instance, in response to receiving the added item event code, theevent manager will first determine whether the local database alreadycontains the unique identifier and a set of details (e.g., product name,expiration date, time out of refrigeration, etc.) associated with thatunique identifier. If the unique identifier and set of details do notexist in the local database, then the event manager knows that this isthe first time the container has been put into the refrigerator (i.e.,it was not put in the refrigerator at some previous time and thentemporarily removed). In this case, the event manager will access thepharmaceutical product database via the interface and search for theunique identifier. If the unique identifier is found in thepharmaceutical product database, then the event manager will copy theset of details associated with the unique identifier from thepharmaceutical product database to the local database via the interface.

If the unique identifier is not found in the local database or thepharmaceutical product database, or if the system cannot access thepharmaceutical database for any reason (such as a network connectionbeing down), then the system will store a record in the local databaseindicating that there is a pharmaceutical product container in the coldstorage compartment with a status that is unknown or suspect (i.e., notverified). Some embodiments of the invention will also send a message tothis effect to an output device, such as a display screen, speaker orprinter. Preferably, the event manager is also configured toperiodically attempt to re-check the pharmaceutical product database toidentify and/or verify containers that have been marked as unknown orsuspect.

On the other hand, if the event manager determines that the localdatabase already contains the unique identifier and a set of detailsassociated with the unique identifier, then the system knows that thecontainer was placed in the refrigerator previously and was temporarilyremoved. In this case, the event manager will record the current timethe pharmaceutical product container was added to the refrigerator,calculate a time out of refrigeration value for the pharmaceuticalproduct container based on the current time and a removal time valuestored in the local database, and increment a counter or database itemconfigured to track the total accumulated time out of refrigeration forthe container.

One of the items in the set of details in the local database contains amaximum time out of refrigeration value for the pharmaceutical productcontainer. Typically, this maximum time out of refrigeration value willbe supplied by the manufacturer. If the total accumulated time out ofrefrigeration counter exceeds the specified maximum time out ofrefrigeration, then the event manager will transmit a warning message tothe human operator, via the output device, indicating this fact.Preferably, the event manager is also configured to transmitinstructions informing the human operator how to properly dispose of theproduct container.

If the human operator removes a pharmaceutical product container fromthe read zone of the antenna, the RFID reader will detect the removaland determine the unique identifier for the container removed. The eventmonitor will then generate and pass to the event manager a “removeditem” event code. In response to receiving the removed item event code,the event manager looks up the unique identifier in the local database,records the time that the pharmaceutical product container with theunique identifier was removed from the read zone of the antenna, andsends a message to the output device containing pertinent details aboutthe container just removed, such as the product name, the time ofremoval, dosing or usage instructions, authenticity status, etc.

In some embodiments of the invention, the cold storage compartmentincludes one or more temperature sensors that monitor the temperature inthe vicinity of the pharmaceutical product containers stored therein. Ifthe temperature rises above or falls below a specified level (e.g.,rises or falls to a level that will negatively affect the quality andefficacy of the compound in one or more pharmaceutical productcontainers), then the event monitor will generate and pass to the eventmanager a temperature event code indicating that there is a temperaturefault. In response to receiving the temperature event code, the eventmanager will transmit a message and/or warning concerning thetemperature fault to the human operator via the output device. Such amessage or warning may comprise, for example, warning beeps or arecorded voice message emanating from an attached speaker, a textmessage flashing on an attached display screen, or some combination ofwarning beeps, voice recordings and flashing text. Some embodiments alsomay be configured to send an email message concerning the fault to ahuman operator via the network interface.

As previously noted, the product identifier may be implemented using avariety of different product identification technologies. Someembodiments use one or more antennas located within the cold storagecompartment, and a radio-frequency identification reader. The antenna isconfigured to convert a radio-frequency field produced by a transponderaffixed to the pharmaceutical product container into alternatingcurrent, and the radio-frequency identification reader is configured todecode the alternating current to determine the unique identifier. Inanother embodiment, the product identifier comprises a barcode readerthat determines the unique identifier by decoding a light energy signalreflected from a barcode label affixed to the pharmaceutical productcontainer. In yet another embodiment, the product identifier comprises amagnetic stripe reader that detects changes in a magnetic field producedby a magnetic stripe affixed to the pharmaceutical product container. Inthis case, the changes in the magnetic field represent the uniqueidentifier.

Some embodiments of the refrigerator also include one or more inputdevices (e.g., keyboard, keypad, mouse, touch screen, etc.) that can beactivated by a human operator to provide operational instructions. Suchoperational instructions may include, for example, instructions to printcertain reports, to change the temperature of the cold storagecompartment, to revise or delete certain items from the local database,or to retry an attempt to connect to a particular manufacturer'spharmaceutical product database. The input devices may also include oneor more biometric sensors (e.g., fingerprint or retina scanners)configured to verify the identity and authorization level of the humanoperator.

If the human operator strikes keys on the keyboard or touches the touchscreen, for example, the event monitor will generate and pass to theevent manager an “input” event code, which will cause the event managerto display a prompt and/or a menu on the display screen. The humanoperator can activate buttons on a keypad, keyboard, mouse ortouch-sensitive display screen to specify what action she wishes to beperformed. The event manager is configured to receive the humanoperator's instructions via the input device, execute the instructions,and then transmit an appropriate message or response to the operator viathe output device.

In some embodiments of the invention, the event monitor is also coupledto a power fail circuit, which is configured to detect a power failurecondition, such as a power outage. When this happens, the event monitorwill generate and pass to the event manager a “power failure” eventcode, which causes the event manager to determine the starting time ofthe power outage, and then store the power failure event code and thestarting time of the power outage in a status log. Preferably, thesystem is configured to accomplish these tasks on a high priority basisas soon as a drop in power is detected but before the power is depleted.Alternatively, the system may be configured to accomplish these taskswhile the system is operating under the support of an emergencytemporary power source, such as a battery or uninterruptible powersupply (UPS). Such an emergency power source may also be used by thesystem to power an internal clock designed to keep track of the currenttime so long as the power failure condition persists.

When the regular power is restored, the event manager is configured towarn the human operator that there has been a power failure and alsocheck the time out of refrigeration status of each pharmaceuticalproduct container inside the refrigerator. In particular, the eventmanager will search the status log for the power failure event code. Ifthe power failure event code is found in the status log, then the eventmanager will transmit the message concerning the power outage to anoutput device and then perform the following actions: (i) determine theduration of the power outage based on the current time and the recordedstarting time of the power outage, (ii) cause the product identifier toread the signals produced by each pharmaceutical product container inthe cold storage compartment to determine their unique identifiers,(iii) search the local database for the time out of refrigerationcounters associated with each unique identifier, and (iv) if the sum ofthe duration and the time out of refrigeration counter for a uniqueidentifier exceeds a specified maximum, then transmit a messageconcerning the unique identifier to an output device. In alternativeembodiments, the event manager may be configured to simply update thetime out of refrigeration counter in the local database for eachpharmaceutical product container, and then check this counter at a latertime as part of a periodic routine.

As will be discussed in more detail below, embodiments of the inventionalso may include one or more external product identifiers for detectingand reading unique identifiers transmitted from transponders affixed topharmaceutical product containers located near the refrigerator but notactually placed inside the refrigerator's cold storage compartment. Aswill be discussed below, a human operator may use the external productidentifiers, for example, to acquire details pertaining to individualpharmaceutical product containers without having to put those containersinto the cold storage compartment. Such external product identifiers mayalso be configured to detect and decode the presence of otherself-identifying items, such as transponder-embedded employee badges oraccess keys, which may be required to operate embodiments of theinvention in secure environments.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention and various aspects, features and advantagesthereof are explained in detail below with reference to exemplary andtherefore non-limiting embodiments and with the aid of the drawings,which constitute a part of this specification and include depictions ofthe exemplary embodiments. In these drawings:

FIG. 1 contains a high-level block diagram illustrating the majorfunctional components of a refrigerator configured to operate accordingto an embodiment of the invention.

FIG. 2 contains an exemplary network in which embodiments of theinvention may be used.

FIGS. 3 through 10 contain high-level flow diagrams illustrating thesteps performed by a refrigerator configured to operate according toembodiments of the invention.

FIG. 11 shows an exterior view of an exemplary embodiment of theinvention.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

With reference to the figures, a detailed discussion of exemplaryembodiments of the invention will now be presented. Notably, theinvention may be implemented using software, hardware, firmware, or anycombination thereof, as would be apparent to those of skill in the artupon reading this disclosure.

FIG. 1 contains a high-level block diagram illustrating the majorfunctional components of an embodiment of the invention. As shown inFIG. 1, refrigerator 100 generally comprises a cold storage compartment110 (such as a refrigerator or freezer), a processor compartment 114 andinput/output devices 112. Cold storage compartment 110 comprises one ormore shelves or other supports (shown in FIG. 1 as shelves 116A and116B) adapted to hold one or more pharmaceutical product containers(shown in FIG. 1 as vaccine vials 102A and 102B) embedded withtransponders configured to transmit self-identifying signals. Aspreviously noted, embodiments of the invention may be used to store avariety of other types of pharmaceutical product containers, includingbut not limited to ampules, syringes, bottles, medication tubes, blisterpacks and cartons. Positioned on, near or within the shelves are RFIDantennas 105A and 105B, which are configured so that theirradio-frequency reception ranges (or “read zones”) encompass any taggedcontainers placed on shelves 116A and 116B. Consequently, when vials102A and 102B are placed on shelves 116A and 116B, antennas 105A and105B will detect the self-identifying radio frequency signals generatedby the transponders attached to or embedded in vials 102A and 102B.

Cold storage compartment 110 also includes a temperature sensor 120(such as a thermometer), which is positioned to monitor the temperaturein the vicinity of shelves 116A and 116B and vials 102A and 102B.Although FIG. 1 illustrates only two shelf supports, two vaccine vialsand one temperature sensor, it is noted that embodiments of theinvention may utilize a multiplicity of shelves capable of holding amultiplicity of vaccine vials, as well as a multiplicity of temperaturesensors. Some embodiments may even be configured to separately measurethe temperatures adjacent to each shelf in the refrigerator. Coldstorage compartments having interior supports, shelves and thermometerssuitable for these purposes are supplied, for example, by GEM ScientificRefrigerator Company (www.gem-scientific.com), located in Philadelphia,Pennsylvania.

Processor compartment 114 comprises a reader 136, event monitor 138,event manager 140, local database 144, re-ordering file 142 and networkinterface 146. Reader 136 is an event-driven RFID reader, whose primaryfunction is to collect, decode and pass on information transmitted tothe antennas 105A and 105B by the transponders embedded in vials 102Aand 102B. RFID readers and antennas suitable for these purposes may beobtained, for example, from Tagsys, USA (www.tagsysrfid.com), located inDoylestown, Pa.

Reader 136 typically passes the unique identifier encoded in theself-identifying signals detected by antennas 105A and 105B to eventmonitor 138. Event monitor 138 comprises a decision-making softwareprogram or programmable logic controller configured to react to thepresence, absence, addition or removal of the self-identifying signalsfrom the read zone of the antennas tied to the reader. Thus, in someembodiments of the present invention, event monitor 138 will generate anevent-identifying code in response to the reader 136 detecting that atagged pharmaceutical product container (such as vial 102A) is currentlylocated inside or has been added to or removed from cold storagecompartment 110. Temperature sensor 120 is also tied to event monitor138 so that event monitor 138 can also generate a temperaturechange-related event code in response to temperature changes in coldstorage compartment 110.

While event monitor 138 determines what kind of event has occurred,event manager 140 selects the course of action to take and carries outthe selected course of action. It is event manager 140, for instance,which checks and updates local database 144 whenever a pharmaceuticalproduct container is added to or removed from cold storage compartment110. When the local database 144 does not contain details associatedwith the unique identifier acquired from the pharmaceutical productcontainer, then event manager 140 utilizes network interface 146 to gainaccess to a remote pharmaceutical product database (not shown in FIG. 1)via data communications network 152. Although FIG. 1 shows event monitor138 and event manager 140 as two distinct components, those skilled inthe computer arts will recognize that a single hardware, software orfirmware component, or alternatively, a multiplicity of distincthardware, software and firmware components may be utilized to implementthe functions performed by event monitor 138 and event manager 140, asdescribed herein, without departing from the spirit or the scope of thepresent invention.

Network interface 146 comprises wired and/or wireless network adaptercards, adapter card drivers, network cables, application programminginterfaces, or modems and routers, as well as other networking softwareand hardware, typically used to connect a personal computer to an onlinedata communications network. The online data communications network,such as data communications network 152 in FIG. 1, may comprise, forexample, a local area network (LAN), a wide area network (WAN), adedicated WAN, a corporate intranet, a virtual private network, or theInternet. Data communications network 152 may also include otherpharmaceutical product refrigerators, similar to refrigerator 100, whichallows users to set up and manage a network of pharmaceutical productcontainer refrigerators operating according to the present invention.

As shown in the box labeled input/output devices 112 in FIG. 1,embodiments of the invention also may include one or more attachedoutput devices, which event manager 140 uses to transmit messages and/orwarnings to a human operator, as well as one or more attached inputdevices, which the human operator can activate to supply commands andinstructions to the refrigerator. In particular, messages and warningsgenerated by event manager 140 can be displayed on touchpad display 122,printed on printer 124 and/or announced on speaker 126. Alternatively,embodiments of the invention can be configured to store information,error messages and warning messages in a local or remote log file (notshown in FIG. 1), which may be accessed by a human operator via the oneor more attached input devices or distributed to human operators viae-mail, web page servers or online information publication servicesaccessible through network interface 146 and data communications link152. Printer 124, operating under the control of event manager 140, canalso print status, inventory, product usage and new information reports,as well as self-adhesive customized pharmaceutical product labels andcustomized dosing instructions that can be affixed to the pharmaceuticalproduct containers as they are placed into or removed from cold storagecompartment 110. The input devices may include a keyboard or mouse(neither of which are shown in FIG. 1), a keypad 130, a microphone 132,a biometric sensor 134 (such as a retina or fingerprint scanner), orsome combination of two or more of these devices. As indicated by thebox in FIG. 1 labeled authentication devices 128, keypad 130, microphone132 and biometric sensor 134 also may be configured to receive andverify security and authorization data, such as user identifications andpasswords. The system may also be configured, for example, to receivesecurity and authorization data through touch-operated menus displayedon the touch-pad display 122.

As will be described in more detail below, some embodiments of theinvention may be configured to notify operators when particularpharmaceutical product inventories fall below certain levels andoptionally prompt the human operator to provide an authorization for thesystem to create and submit a new order to a pharmaceutical manufacturervia network interface 146 and data communications network 152.Therefore, some embodiments of the invention may include auser-configurable re-ordering file 142, which stores a set of userpreferences associated with certain pharmaceutical products. Eventmanager 140 can utilize the data in re-ordering file 142 toautomatically create and submit orders. Alternatively, the re-orderinginformation for pharmaceutical products can be stored in the localdatabase along with the other details and attributes of thosepharmaceutical products. In the case of a data communications network(such as a corporate LAN) comprising multiple pharmaceutical productrefrigerators, inventory and re-ordering information for the multiplerefrigerators may be consolidated and stored in a centralized databaseso that purchasing decisions and new orders can be based on theconsolidated inventory information for all of the refrigerators in acompany or organization, rather than just a single refrigerator in thenetwork. Preferably, the human operator can create and edit there-ordering file 142 by using a keyboard, a mouse, or both (not shown inFIG. 1), or by activating and using touch-enabled menu screens displayedon touchpad display 122.

The embodiment of the invention shown in FIG. 1 also includes anexternal reader 160, external antennas 146 and 148, and disposal 150.External reader 160 and antenna 146 will detect and readself-identifying signals produced by transponders attached topharmaceutical product containers that are located outside of coldstorage compartment 110, but which are still within the read zone ofantenna 146. External reader 160 and external antenna 146 are providedso that a human operator can easily obtain pertinent details concerningindividual product containers without putting those individual productcontainers into cold storage compartment 110.

Suppose, for example, that the refrigerator is configured so thatpharmaceutical product containers are stored inside cold storagecompartment 110 in trays, and that each tray is capable of holding alarge number of pharmaceutical product containers (say, twenty or thirtyindividual containers per tray). Suppose further that a human operatorremoves an entire tray from cold storage compartment 110, which causesthe internal antennas 105A and 105B, reader 136, event monitor 138 andevent manager 140 to cooperate to produce a warning message on touchpaddisplay 122, printer 124, speaker 126, or all of them. The warningmessage indicates that, according to the details stored in localdatabase 144, one or more of the pharmaceutical product containers inthe removed tray should be destroyed or returned because it has expiredor been recalled by the manufacturer.

At this point, however, the human operator may be holding a traycontaining perhaps twenty or thirty containers. Therefore, it may not beimmediately obvious, depending on the warning message and/or the numberof containers in the tray, which containers are bad. One method thehuman operator can use to determine which containers are bad is toremove individual containers from the tray and return each of them tocold storage compartment 110 one at a time, keeping track of theindividual containers that trigger additional warning messages. It isfar safer, as well as far less cumbersome and time-consuming, however,for the human operator to separately move each of the individualcontainers into the read zone of the external antenna 146, so thatexternal reader 160 (which, like reader 136, is also coupled to eventmonitor 138 and event manager 140) can determine and indicate viasubsequent status and warning messages which containers are bad. Thus,there will be no need to put expired and/or recalled pharmaceuticalproduct containers back into cold storage compartment 110.

Preferably, the human operator can place the bad pharmaceutical productcontainers in an attached receptacle for disposal (disposal 150 inFIG. 1) having another antenna (antenna 148 in FIG. 1), which is alsoattached to external reader 160 (as shown in FIG. 1) or alternatively,attached to reader 136. When antenna 148 detects a self-identifyingsignal produced by a pharmaceutical product container placed in disposal150, event monitor 138 is configured to generate a “discarded product”event code indicating that the identified pharmaceutical productcontainer has been discarded by the human operator. Upon receiving thediscarded product event code, event manager 140 is configured to updatethe local database to reflect this fact, and print, display or announcean appropriate message for the human operator via one or more of theoutput devices.

Disposal 150 can also be used to discard empty pharmaceutical productcontainers—that is, containers for pharmaceutical products that havealready been dispensed. The fact that the product has already beendispensed could then be stored in the local database by event manager140 and, optionally, uploaded to the manufacturer's pharmaceuticalproduct database. Thereafter, if a pharmaceutical product containerhaving the same unique identifier appears in this or anotherrefrigerator, users and manufacturers could be warned that the containermay in fact be counterfeit. The event manager 140 may also be configuredto ask the user, via touchpad display 122, for example, whether thediscarded pharmaceutical product should be automatically re-orderedbased on data stored in re-ordering file 142.

Although not shown in FIG. 1, embodiments of the present invention alsoinclude an emergency power supply, such as a battery and/oruninterruptible power supply (UPS), which will be activated in case of apower failure, thereby reducing the risk that a significant number ofpharmaceutical product containers would have to be discarded due to aloss of power, and also providing the system with sufficient powerduring a power failure to carry out a predetermined power failureroutine.

Embodiments of the present invention may be practically applied in avariety of different settings where refrigerated pharmaceutical productsare usually stored, dispensed and/or administered, including forexample, physicians' offices, hospitals and pharmacies. But theinvention may also provide significant advantages outside of the usualsettings, such as in homes and mobile clinics, which increasingly haveconstant high-speed wired and wireless connections to datacommunications networks, such as the Internet. Diabetes patients, forinstance, frequently need to store insulin in home refrigeration unitsfor significant periods of time. Physicians combating the spread ofviruses and disease in the field often have to work out of mobileclinics, such as vans, that house, among other things, refrigerationunits containing refrigerated vaccines. In these situations, embodimentsof the present invention may be used (either as stand-alone units, oralternatively, as part of an upgrade kit for a conventionalrefrigerator) to provide potentially critical details about theauthenticity, quality and status of pharmaceutical products at the timeand place where they will be used.

FIG. 2 illustrates, by way of example, a networked environment in whichembodiments of the present invention may be beneficially implemented. Asshown in FIG. 2, network 200 comprises a multiplicity of intelligentrefrigerator users (shown in FIG. 2 as physician's office 205, home 207,hospital 215, mobile clinic 220 and pharmacy 225), which utilize amultiplicity of refrigerators 210, 212, 214, 216 and 218, respectively,to store pharmaceutical product containers. Refrigerators 210, 212, 214,216 and 218 are configured to operate substantially in the same manneras refrigerator 100 described above with reference to FIG. 1. Thus,refrigerators 210, 212, 214, 216 and 218 each contain networkinterfaces, which enable refrigerators 210, 212, 214, 216 and 218 toconnect, via data communications network 265, to a multiplicity ofpharmaceutical product databases 235, 240 and 245. The pharmaceuticalproduct databases are typically operated by the manufacturers of thepharmaceutical product containers.

To facilitate the communication and download functions betweenrefrigerators 210, 212, 214, 216 and 218, on the one hand, andpharmaceutical product databases, on the other, data communicationsnetwork 265 comprises one or more object naming servers (shown in FIG. 1as ONS 290 and ONS 292), which provide object naming services (“ONS”)for RFID tags. Similar to the role played by directory naming service(DNS), which provides root directory naming services on the Internet,ONS servers store and provide directory information for registeredelectronic product codes (EPCs) assigned to individual objects thatcarry RFID transponders. Each EPC is a unique identification number(like a serial number) that enables manufacturers, retailers,wholesalers and end-users to track goods as they move through theirinventories and throughout the world. Pharmaceutical manufacturersregister their EPCs with ONS server operators, who program the ONSservers to provide Internet protocol addresses for the manufacturers'online pharmaceutical product databases. The online pharmaceuticalproduct databases supply pharmaceutical product container details toclient computer systems according to an industry standard known as theEPC information service (EPCIS). Currently, Verisign, Inc.(www.verisign.com), of Mountain View, Calif., manages and operatesInternet-based ONS servers for use by the public, in conjunction withEPCglobal, Inc. (www.epcglobaling.org), a not-for-profit consortium ofRFID industry leaders, which provides industry-driven standards anddesigns for a rapidly-expanding Internet-based EPCIS network. Thus, asshown in FIG. 2, each one of the pharmaceutical product databases 235,240 and 245 comprises an EPCIS-enabled server (shown in FIG. 2 as EPCIS237, EPCIS 242 and EPCIS 247), which provides access to detailscontained in that pharmaceutical product database.

When a refrigerator of the present invention (such as refrigerator 210)connects to the data communications network 265 and supplies an ONSserver (such as ONS 290 or ONS 292) with a registered unique identifier(EPC) embedded in a transponder attached to a pharmaceutical productcontainer, the ONS server responds by providing the refrigerator withthe Internet protocol address for an EPCIS-enabled pharmaceuticalproduct database. Having obtained the appropriate Internet protocoladdress from the ONS server, the refrigerator can then connect (again,via data communications network 265) to the manufacturer's EPCIS-enabledpharmaceutical product database and retrieve details associated with theunique identifier (and, hence, the particular container). Whereinformation security is a concern, the information transmitted betweenthe refrigerator 210 and the manufacturer's EPCIS-enabled pharmaceuticalproduct database via the data communications network may be encrypted.

By utilizing ONS and EPCIS, embodiments of the present invention may beconfigured to provide critical information concerning the distributionand status of refrigerated pharmaceutical product containers to otherinstitutions which have an interest in tracking this kind ofinformation. For instance, institutions such as medical research firmsand universities, the National Institute of Health (NIH) and the Foodand Drug Administration (FDA) (which are represented in FIG. 2 asresearch institution 250, National Institute of Health 255, and Food andDrug Administration 260) can also be connected to a multiplicity ofintelligent pharmaceutical product refrigerators via data communicationsnetwork 265. Therefore, if there were a sudden outbreak of a particularvirus or disease, the National Institute of Health or the Centers forDisease Control (CDC), for instance, could rapidly determine through theinvention and the data communications network the quantity and locationswhere the necessary vaccines are stockpiled and/or stored. On the otherhand, the FDA, which, among other things, monitors newly discoveredadverse events associated with drugs and vaccines, also may need todetermine rather quickly where such drugs and vaccines are currentlylocated throughout the country. Embodiments of the present inventionmake it possible for these organizations to quickly collect this kind ofdetailed information.

FIGS. 3 through 10 contain high-level flow diagrams illustrating thesteps performed by a refrigerator configured to operate according toembodiments of the invention. These steps would be performed, forexample, by event monitor 138, event manager 140, or both of them, asdescribed above with reference to FIG. 1.

FIG. 3 illustrates the initialization procedures for embodiments of theinvention. When the system is first powered on at step 305 of FIG. 3,event manager 140 checks the status log to determine, for example,whether there has been a status anomaly (see steps 310 and 315). Astatus anomaly may include, for instance, a power outage, a door beingleft open, the refrigerator being completely full, or any other problemor malfunction pertaining to the refrigerator itself, as opposed statusproblems pertaining to the pharmaceutical products containers inside therefrigerator. If a status anomaly has occurred, then processingcontinues at step 805 of FIG. 8 by way of flow chart connector “FL8.”The anomaly procedures are discussed in more detail below with referenceto FIG. 8. If it is determined at step 315 that no status anomaly hasoccurred, then the system determines, at step 320, whether the operatorhas caused an input event by, for example, striking keys on the keypador activating the touchpad display. If an input event has occurred, thesystem checks whether the input event comprises a request to quit theprogram (step 325). If the answer is yes, then the program (e.g., eventmanager 140) terminates. But if the input event was not a request toterminate, then processing continues at step 330, where the systemdetermines whether the operator has requested a printed report. If theanswer is yes, then the system enters the print report procedures (step335) and processing continues at step 1005 of FIG. 10 by way of flowchart connector “FL10.” The print report procedures are discussed belowwith reference to FIG. 10. If it is determined at step 330 that theoperator did not request a printed report, then the system loops back tostep 320 to check for the next event by way of step 340.

If it is determined at step 320 that an event other than an input eventoccurred, then the system next determines, at step 345, which type ofevent occurred. Embodiments of the invention are configured to determinewhen pharmaceutical product containers are added or removed from thecold storage compartment, as well as when one of the external antennashas picked up a signal from a pharmaceutical product container locatedoutside of the cold storage compartment. Thus, if it is determined atstep 345 that a pharmaceutical product container has been added to thecold storage compartment, then an “added item” event code is generated(step 355) and processing will continue at step 405 of FIG. 4 by way offlow chart connector “FL4.” If it is determined at step 345 that apharmaceutical product container was removed from the cold storagecompartment, then a “removed item” event code is generated (step 360)and processing continues at step 505 of FIG. 5 by way of flow chartconnector “FLS.”

Some embodiments of the invention are configured to determine on aperiodic basis, whether certain problems have occurred, such as atemperature or database detail problem. These are referred to as “timerevents.” Therefore, if it is determined at step 345 that a timer eventhas occurred, then a timer event code is generated (step 350) andprocessing will continue at step 605 of FIG. 6 by way of flow chartconnector “FL6.” And finally, if it is determined at step 345 that apharmaceutical product container was brought within the read zone of anexternal antenna, then an “external read” event code will be generated(step 365) and processing will continue at step 905 of FIG. 9 by way offlow chart connector “FL9.” The added item, removed item, timer eventand external read event procedures are discussed in detail below withreference to FIGS. 4, 5, 6, 7 and 9.

FIG. 4 contains a flow diagram illustrating the identificationprocedures certain embodiments of the invention will execute if an addeditem event occurs (i.e., if a pharmaceutical product container has beenadded to the cold storage compartment). As shown in FIG. 4, the firststep (step 405) is to read the tag (i.e., the unique identifier or EPC)transmitted by the transponder attached to the pharmaceutical productcontainer. At step 410, the system determines whether the tag alreadyexists in the local database. If the tag already exists in the localdatabase, then the pharmaceutical product container must have alreadybeen in the cold storage compartment at some point in the past, but wastemporarily removed. Therefore, the next step (step 415 in FIG. 4) is tocalculate the change in the total amount of time the pharmaceuticalproduct container has been out of the cold storage compartment (i.e.,the delta for the container's total time out of refrigeration) andupdate an appropriate counter in the local database. One way to performthis calculation is to maintain in the set of details associated withthe pharmaceutical container a detail indicating the time the containerwas removed from the cold storage compartment (as done in step 530 ofFIG. 5, which is discussed below). Then, when the container is added tothe cold storage compartment, the time of removal detail is retrievedfrom the local database and compared to the current time. The currenttime may be obtained, for example, from an internal clock, oralternatively, from an Internet- or network-accessible clock. Thedifference between the current time and the time of removal equals thedelta in the time out of refrigeration for the container. The delta isthen added to a prior total time out of refrigeration value (alsoretrieved from the set of details in the local database) to obtain anupdated total time out of refrigeration for the container. The updatedtotal time out of refrigeration is then stored in the local database.

In some embodiments, the system will at this point compare the updatedtotal time out of refrigeration to a specified maximum time out ofrefrigeration for the container and, if appropriate, transmit a warningmessage to the operator. In other embodiments, the procedure forcomparing the updated total time out of refrigeration to the specifiedmaximum will be performed as part of the timer event processing (seesteps 765, 770 and 775 of FIG. 7, discussed below).

If it is determined at step 410 that the tag does not already exist inthe local database, then the container has probably never been insidethe cold storage compartment. Therefore, the system adds the new tag tothe local database (step 420) and checks whether the system has accessto preloaded manufacturer data residing in another memory storagelocation attached to the system, such as on a permanent or removabledisk drive, CDROM, tape device or flash memory device (step 425). If thepreloaded manufacturer data is not available, then the system determineswhether the Internet (or another data communications network) isavailable (step 430). If the Internet is also not available, then thesystem will store in the local database a marker indicating that thecontainer associated with the new tag is suspect (step 470) and theadded item processing then comes to an end.

But if the Internet is available, then at step 435 the system will lookup the details for the tag (and the container) in a remotepharmaceutical product database (using ONS and EPCIS, for example). Ifthe tag and the details exist in the remote pharmaceutical productdatabase (step 440), then the system copies the details from the remotepharmaceutical product database to the local database (step 445),increments any inventory counters in the local database (step 465) andterminates processing. If the tag and details are not found in theremote pharmaceutical product database, however, then the system storesin the local database a marker indicating that the container associatedwith the new tag is suspect (step 470) and terminates processing. Aswill be discussed below and with reference to FIG. 7, the system ispreferably configured to automatically retrieve the suspect markers andattempt to verify and/or authenticate the suspect product containers ata later time when, for example, access to the Internet (or other datacommunications network) or pharmaceutical product database has beenreestablished, or when the pharmaceutical product database may have beenupdated to include information concerning the suspect containers.

If it is determined at step 425 that preloaded manufacturer data isavailable, then the system searches the preloaded manufacturer data forthe tag (step 450). If the tag and associated details are found in thepreloaded manufacturer data, then the details associated with the newtag are copied from the preloaded manufacturer data to the localdatabase (step 460), the inventory counters are incremented (step 465)and processing comes to an end. But if the tag and details are not foundin the preloaded manufacturer data, then processing will continue atstep 430, where the system looks for the tag and data on the Internet(as described above).

FIG. 5 contains a high-level flow diagram illustrating the stepsperformed by embodiments of the invention when a pharmaceutical productcontainer is removed from the cold storage compartment. As shown in FIG.5, the first steps are to read the tag for the removed item (step 505)and attempt to retrieve the details for the tag from the local database(steps 510 and 515). If the details for the removed container do notexist in the local database, then the system has no record of acontainer being stored in the cold storage compartment. Therefore, thesystem displays, prints and/or announces a suitable warning (step 570)to inform the operator. However, if there are details in the localdatabase for the tag, then the system determines whether the tag hasbeen marked as suspect (step 520). If the answer is yes, then againprocessing will proceed at step 570, where the system will display,print and/or announce a suitable warning or error message for theoperator.

If the details for the tag exist in the local database and have not beenmarked as suspect, then the system decrements any inventory counters forthe pharmaceutical product (step 525), and, at step 530, records thetime the container was removed from the cold storage compartment andnotes in the local database that the container has been removed. Someembodiments will also determine at this time whether the removedcontainer has expired (step 535), exceeded its maximum time out ofrefrigeration (step 540) or been recalled (step 545). If any of theseconditions are true, then the system again displays, prints and/orannounces an appropriate error message or warning for the operator (step570). But if none of these conditions are true, then the systemdisplays, prints and/or announces that the container has been removed(step 550), and prints a label for the container if instructed to do soby the operator (steps 555, 560 and 565).

FIGS. 6 and 7 contain a high-level flow diagram illustrating the stepsperformed by embodiments of the invention when a timer event occurs. Asshown in FIG. 6, the first steps are to read a temperature sensor in thecold storage compartment and compare the reading to data stored in anenvironment database to determine if a temperature fault has occurred(steps 605, 610 and 615). If a temperature fault has occurred, then thesystem will display, print or announce an appropriate error message(step 620). If the reading indicates that no temperature fault hasoccurred, then the system will continue looping through steps 605, 615and 625 until all temperature sensors have been read. When all of thetemperature sensors have been read, processing will continue at step 705of FIG. 7 by way of flow chart connector “FL7.”

At steps 705 and 710 of FIG. 7, the system reads a tag for apharmaceutical product container located inside the cold storagecompartment and then determines (at steps 710, 715, 720 and 725) whetherthe data can be found in the local database or in a product databaselocated on the Internet. If the details for the tag are found only inthe pharmaceutical product database and not in the local database, thenthe system will copy the details from the pharmaceutical productdatabase to the local database (step 735) and increment the appropriateinventory counters (step 740). But if the details for the tag are notfound in either database, then the system marks the container as suspect(step 730) and loops back to step 705 to begin processing the next tag.The system is configured to continue looping in this manner until all ofthe tags inside the cold storage compartment have been read (see step795).

Once the details have been copied into the local database, the systemnext determines whether there is an inventory shortfall for the tag(steps 745 and 750). If so, the system displays an inventory shortfallmessage (step 755). In some embodiments, the system automatically ordersadditional products from the manufacturer (step 760). In otherembodiments, the system prompts the user to order additional products bymanual methods or sends an inventory shortfall notification message to acentralized inventory database so that re-ordering and purchasingdecisions can be made using the inventory data from multiplerefrigerators. Next, the system determines, at steps 765 and 770,whether the total time out of refrigeration for the tag exceeds aspecified maximum. If so, then the system displays a message to theoperator indicating this fact (step 775). Next, the system determineswhether the product has expired (steps 780 and 785) and, if so, displaysan appropriate message to that effect (step 790). All of these checksare determined for each container in the cold storage compartment (seestep 795). When all of the containers and all of the temperature sensorshave been checked, timer event code processing comes to an end.

FIG. 8 contains a high-level flow diagram illustrating the stepsperformed by embodiments of the invention when an anomaly event code isgenerated. As shown in FIG. 8, the system first determines, at steps 805and 810, whether a power outage has occurred. If not, the system may beconfigured to determine whether some other type of anomaly has occurred,such as a door being open, the refrigerator being at full capacity, amalfunction of an antenna, thermometer, printer, biometric sensor, orsome other physical or functional problem (step 855), in which case thesystem will transmit the appropriate error message to an output device(step 860) and terminate processing. However, if it is determined atstep 810 that a power outage has occurred, then the system determinesthe duration of the power outage (step 815), reads a tag on a containerlocated in the cold storage compartment (step 820), retrieves thedetails for the tag from the local database (steps 825 and 830), andupdates the total time out of refrigeration (TOR) counter for the tag(step 835). Next, the system compares the total time out ofrefrigeration (TOR) counter to a specified maximum time out ofrefrigeration (step 840). If the total time out of refrigeration (TOR)exceeds the specified maximum, then the system transmits an appropriatewarning message to the operator via an output device (step 845). Thesystem will then loop back to step 820 to begin processing the next tagfor the next container in the cold storage compartment (see step 850).When all of the containers in the cold storage compartment have beenprocessed, the anomaly event code processing comes to an end.

FIG. 9 contains a high-level flow diagram illustrating the stepsperformed by embodiments of the invention when an external read eventcode is generated. As shown in FIG. 9, the system first performs thesame steps illustrated in FIGS. 4 and 5 and which were discussed abovewith reference to the added item and removed item event codes. Next, atstep 905, the system asks the operator whether the product containercontents are being used or discarded. If the answer is yes, then thesystem prints a message advising the operator to properly dispose of thecontainer (step 915), removes the tag and associated details from thelocal database (step 920) and optionally sends a message to themanufacturer, via the network interface, that the container has beendiscarded (step 930). Supplied with the discarded container information,it will be easier for the manufacturer (or other interested parties) toidentify as counterfeit containers having the same tag. The system mayalso be configured to prompt the user for permission to update are-ordering file so that the used or disposed product may beautomatically re-ordered.

FIG. 10 contains a high-level flow diagram illustrating the stepsperformed by embodiments of the invention when the operator hasrequested a printed report. As shown in FIG. 10, the system firstdisplays a report menu and prompts the operator to select the reportdesired (steps 1005 and 1010). If the operator selects an inventoryreport, the system will produce (and optionally print) an inventoryreport based on data retrieved from an inventory file or database (steps1015, 1020 and 1025). If the operator selects a usage report, the systemwill produce (and optionally print) a usage report based on dataretrieved from an optional usage file or database (steps 1030, 1035 and1040). If the operator elects to receive a report containing any newinformation about the pharmaceutical product, the system will produce(and optionally print) a report containing the new information based ondata retrieved from an optional new information file or database (steps1045, 1050 and 1055). Preferably, the system is configured to loopthrough these reporting options until the operator quits out of thereport menu (steps 1060 and 1065).

FIG. 11 shows an exterior view of an exemplary embodiment of theinvention as it might be viewed from a viewpoint that lies approximatelyhalfway between the front and side perspective views. The embodimentdepicted in FIG. 11 illustrates by way of example one possibleconfiguration for the cold storage compartment 1105, processorcompartment 1110 and input/output devices 1115, which are discussed ingreater detail above and with reference to FIG. 1. In the embodimentshown in FIG. 11, input/output devices 1115 includes a keypad 1120,which may be activated by a human operator to enter security codesand/or operating instructions for the refrigerator, and a touchpaddisplay 1125 configured to display to the human operator error messages,information and warnings associated with pharmaceutical productcontainers inside the refrigerator, as well as information related tothe operational status of the refrigerator itself Touchpad display 1125may also be configured to accept menu-based commands and instructionsfrom a human operator. FIG. 11 also illustrates one possible arrangementfor the shelves inside the cold storage compartment (shown in FIG. 11 asshelves 1130A and 1130B), upon which the pharmaceutical productcontainers may be stored. In the exemplary embodiment depicted in FIG.11, shelves 1130A and 1130B can be seen through a window of transparentor semi-transparent glass or plastic embedded in the door of the unit.

Although the exemplary embodiments, uses and advantages of the inventionhave been disclosed above with a certain degree of particularity, itwill be apparent to those skilled in the art upon consideration of thisspecification and practice of the invention as disclosed herein thatalterations and modifications can be made without departing from thespirit or the scope of the invention, which are intended to be limitedonly by the following claims and equivalents thereof It should berecognized by those skilled in the art, for instance, that while one ofthe embodiments disclosed herein relies on the generation and use ofevent codes, alternative embodiments of the invention may be implementedwithout generating and using such event codes, and that such alternativeembodiments fall within the scope of the claimed invention.

What is claimed is:
 1. A cold storage system for pharmaceutical productcontainers, comprising: a refrigeration unit housing a cold storagecompartment configured to hold a plurality of pharmaceutical productcontainers; a local database for storing information associated with theplurality of pharmaceutical product containers located in the coldstorage compartment; a product identifier configured to determine aunique identifier for a pharmaceutical product container added to thecold storage compartment; and a processor configured to determine, basedon the information in the local database and the unique identifier, (i)whether the added pharmaceutical product container was previouslyremoved from the compartment, (ii) a length of time that the addedpharmaceutical product container was most recently removed from thecompartment, and (iii) an updated total time out of refrigeration valuefor the pharmaceutical product container, wherein the processorcalculates the updated total time out of refrigeration value byretrieving a prior total time out of refrigeration value from the localdatabase and adding thereto said most recently removed length of time;wherein the processor is further configured to modify the information inthe local database to include the length of time that the addedpharmaceutical product container was most recently removed and theupdated total time out of refrigeration value.
 2. The cold storagesystem of claim 1, wherein the processor is further configured to causea message concerning the added pharmaceutical product container to bedelivered to a human operator, the message including at least one of:the unique identifier, the length of time elapsed since the addedpharmaceutical product container was previously removed from the coldstorage compartment, and the updated total length of time that the addedpharmaceutical product container has been removed from the cold storagecompartment.
 3. The cold storage system of claim 1, wherein theprocessor causes the message to be delivered to the human operator viaat least one of: an information store, a log file, an attached outputdevice, an email communication program, a web page server, and an onlineinformation publication service.
 4. The cold storage system of claim 1,wherein: the processor is electronically coupled to a clock configuredto provide a current date; the information in the local databaseincludes a record specifying an expiration date for the addedpharmaceutical product container; and the processor is furtherconfigured to (i) determine an expiration status for the addedpharmaceutical product container by comparing the current date to theexpiration date, and (ii) cause a warning to be delivered to the humanoperator concerning the expiration status of the pharmaceutical productcontainer.
 5. The cold storage system of claim 1, wherein: theinformation in the local database includes a record specifying a maximumtime out of refrigeration value for the added pharmaceutical productcontainer; and the processor is further configured to (i) determine aspoliation status for the pharmaceutical product container by comparingthe updated total length of time to the maximum time out ofrefrigeration value, and (ii) cause a warning to be delivered to thehuman operator concerning the spoliation status of the pharmaceuticalproduct container.
 6. The cold storage system of claim 1, wherein: theprocessor is electronically coupled to a clock configured to provide acurrent time; the information in the local database comprises a recordfor storing (i) a removal time indicating a time that the addedpharmaceutical product was previously removed from the cold storagecompartment, and (ii) a prior total length of time that the addedpharmaceutical product container has been removed from the cold storagecompartment; and the processor determines the updated total length oftime that the pharmaceutical product container has been removed from thecold storage compartment by retrieving the current time from the clock,retrieving the removal time and the old total length of time from thelocal database, subtracting the removal time from the current time toobtain a duration, and adding the duration to the prior total length oftime.
 7. The cold storage system of claim 1, wherein if the processordetermines that the added pharmaceutical product container was notpreviously removed from the cold storage compartment, then the processorwill cause the time that the added pharmaceutical product container wasadded to the cold storage compartment to be recorded in the localdatabase.
 8. The cold storage system of claim 7, further comprising: aninterface to a pharmaceutical product database; wherein the processor isfurther configured to (i) determine whether the pharmaceutical productdatabase contains a set of details associated with the uniqueidentifier, and (ii) cause a copy of the set of details to be copiedfrom the pharmaceutical product database to the local database via theinterface.
 9. The cold storage system of claim 8, wherein if theprocessor determines that the pharmaceutical product database does notcontain a set of details associated with the unique identifier, then theprocessor will (i) create a record in the local database indicating thatthe authenticity of the pharmaceutical product container is suspect, and(ii) cause a warning to be delivered to the human operator concerningthe suspect authenticity of the pharmaceutical product container. 10.The cold storage system of claim 1, wherein the product identifiercomprises an RFID reader and an antenna.
 11. The cold storage system ofclaim 1, wherein the product identifier comprises a barcode reader. 12.A cold storage system for pharmaceutical product containers, comprising:a cold storage compartment configured to hold a plurality ofpharmaceutical product containers; a product identifier configured todetermine a unique identifier for a pharmaceutical product containeradded to the cold storage compartment; a local database comprising arecord correlating the unique identifier with a prior total time out ofrefrigeration value for the pharmaceutical product container; a powerfail circuit for detecting a power failure condition for therefrigerator; and a processor, electronically coupled to the productidentifier, the local database and the power fail circuit, thatdetermines a duration for the power fail condition, calculates a newtotal time out of refrigeration value for the pharmaceutical productcontainer by retrieving the prior total time out of refrigeration valuefrom the local database and adding the duration to the prior total timeout of refrigeration value, and stores the new time out of refrigerationvalue in the local database.
 13. The cold storage system of claim 12,wherein the processor is further configured to cause a messageconcerning the power failure condition to be delivered to a humanoperator via one or more of an information store, a log file, anattached output device, an email communication, a web page server, andan online information publication service.
 14. A cold storage system forpharmaceutical product containers, comprising: a refrigeration unithousing a cold storage compartment configured to hold a plurality ofpharmaceutical product containers; a product identifier configured todetermine a unique identifier for a pharmaceutical product containeradded to the cold storage compartment; a local database comprisingrecords correlating the plurality of unique identifiers with a pluralityof details associated with the plurality of pharmaceutical productcontainers located in the cold storage compartment; and a processorconfigured to determine, based on the plurality of unique identifiersand the plurality of details in the local database, whether apharmaceutical product container has been removed from the cold storagecompartment; wherein the processor is configured to (i) record in thelocal database the time that the pharmaceutical product container wasremoved from the cold storage compartment, and (ii) cause a message tobe delivered to a human operator indicating that the pharmaceuticalproduct container was removed from the cold storage compartment; andwherein the processor is configured to determine an updated total timeout of refrigeration value for the pharmaceutical product container byretrieving a prior total time out of refrigeration value from the localdatabase and adding thereto a length of time that the pharmaceuticalproduct container was most recently removed from the cold storagecompartment.
 15. The cold storage system of claim 14, wherein theprocessor is further configured to determine, based on the uniqueidentifier and the plurality of details in the local database, anexpiration status for the pharmaceutical product container removed fromthe cold storage compartment, and cause a message concerning theexpiration status to be delivered to the human operator.
 16. The coldstorage system of claim 14, wherein the processor is further configuredto determine, based on the unique identifier and the plurality ofdetails in the local database, a recall status for the pharmaceuticalproduct container removed from the cold storage compartment, and cause amessage concerning the recall status to be delivered to the humanoperator.
 17. The cold storage system of claim 14, wherein: theplurality of details in the local database comprises a record indicatinga specified maximum time out of refrigeration value for thepharmaceutical product container; and the processor is furtherconfigured to determine, based on the updated total time out ofrefrigeration value and said specified maximum time out of refrigerationvalue, a spoliation status for the pharmaceutical product containerremoved from the cold storage compartment, and cause a messageconcerning the spoliation status to be delivered to the human operator.18. The cold storage system of claim 14, wherein: the cold storagecompartment includes a temperature sensor that measures the temperaturein the cold storage compartment; and the processor periodically comparesthe temperature measured by the temperature sensor to a specifiedtemperature value and, if the temperature differs from the specifiedtemperature value, generates an alert concerning the temperature.
 19. Acold storage system for pharmaceutical product containers, comprising: arefrigeration unit housing a cold storage compartment configured to holda plurality of pharmaceutical product containers; a local database forstoring information associated with the plurality of pharmaceuticalproduct containers located in the cold storage compartment; a productidentifier configured to determine a unique identifier for apharmaceutical product container recently removed from the cold storagecompartment; a processor configured to determine, based on theinformation in the local database and the unique identifier, whetherthere is a problem associated with the recently removed pharmaceuticalproduct container; and an output device, operable with the processor, todeliver a warning message to a human operator about the problem; whereinthe problem comprises one or more of the following conditions: (i) therecently removed pharmaceutical product container has exceeded a maximumtime out of refrigeration value, (ii) the recently removedpharmaceutical product container has been recalled; (iii) the recentlyremoved pharmaceutical product container is suspected of beingcounterfeit, (iv) the pharmaceutical product inside the recently removedpharmaceutical product container has a known contraindication, (v) thepharmaceutical product inside the recently removed pharmaceuticalproduct container has expired, and (vi) the number of pharmaceuticalproduct containers remaining in the cold storage compartment containingthe pharmaceutical product inside the recently removed pharmaceuticalproduct container has fallen below a specified threshold.
 20. The coldstorage system of claim 19, wherein the product identifier comprises anRFID reader or a barcode reader.